Recruiting

Closed Loop Spinal Cord Stimulation

Sponsor:

Scripps Health

Code:

NCT06421350

Conditions

Complex Regional Pain Syndromes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Spinal Cord Stimulation Device

Study Details

Brief summary:

The primary purpose of this study is to determine the differences in response to treatment of complex regional pain syndrome with a closed-loop spinal cord stimulator if applied in the early phases (acute or subacute) versus the chronic phase.

Conditions

Complex Regional Pain Syndromes

Study ID

NCT06421350

Start date

Sep 3, 2024

Status verified date

Oct, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years or older
  • neuromodulation naive patients with unilateral CRPS type 1 or type 2 (defined by Budapest Criteria)
  • pre-procedure psychological clearance

Exclusion Criteria:

  • younger than 18 years
  • prior neuromodulation including spinal cord stimulation
  • prior dorsal root ganglion stimulation
  • prior peripheral nervous system stimulation
  • anatomical obstacles to dorsal column lead placement

Study Design

Enrollment

32 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acute and Subacute Phases of CRPS

Participants diagnosed with acute and subacute phases of CRPS will be assigned to this group.

experimental: Chronic Phase of CRPS

Participants diagnosed with chronic CRPS will be assigned to this group.

Interventions

Spinal Cord Stimulation Device

The closed-loop spinal cord stimulation mechanism uses dynamic adjusting stimulation parameters based on real-time physiologic response and is uniquely positioned to mitigate the aberrant inflammatory and neurosensory processing and autonomic dysfunction driving CRPS and its progression between phases.

Primary outcome measure

  • Change in Complex Regional Pain Syndrome Severity Scores [ Time Frame: Baseline, 7 day trial period, 3 months, 6 months ]
  • Change in Target Activation Amplitude Levels by the Spinal Cord Stimulation Device [ Time Frame: 7 day trial period, 3 months, and 6 months. ]

Central Contacts and Locations

Central contacts

Julie C McCauley

585-554-7122mccauley.julie@scrippshealth.org

Roslyn M Kackman

858-554-7122kackman.roslyn@scrippshealth.org

Locations

Scripps Clinic Torrey Pines

Recruiting

La Jolla, California, United States, 92037

Contacts

Julie C McCauley

585-554-7122mccauley.julie@scrippshealth.org

Roslyn M Kackman

858-554-7122kackman.roslyn@scrippshealth.org

Principal Investigator:

David B Hiller, MD

More Information

Sponsor

Scripps Health

Last update posted

Nov 3, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scripps Health on 2025-11-03.